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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services EQP Name: Standard_EQP SFC.01.08 Service Type: OQ Company Name: _________________________ Customer Name/Title: _________________________ EQP Filename: EQP Release Date: July 2017 Print Date: April 3, 2018 10:37:43 AM Standard_EQP SFC.01.08.eqp Page 1 / 15 April 3, 2018 10:37:43 AM Standard_EQP SFC.01.08

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Page 1: EQP Name: Standard EQP SFC.01 - Agilent · PDF fileEQP Name: Standard_EQP SFC.01.08 Service Type: OQ Company Name: _____ Customer Name/Title: _____ EQP Filename: EQP

© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

EQP Name: Standard_EQP SFC.01.08

Service Type: OQ

Company Name: _________________________

Customer Name/Title: _________________________

EQP Filename:

EQP Release Date: July 2017

Print Date: April 3, 2018 10:37:43 AM

Standard_EQP SFC.01.08.eqp

Page 1 / 15 April 3, 2018 10:37:43 AMStandard_EQP SFC.01.08

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Table of ContentsSection Page

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Scope and PurposeOverview

The Equipment Qualification Plan (EQP) documents the activity program that is performed during the qualification services for the

applicable systems. A complete description of the test specifications is provided for the supported services, including setpoints and

acceptance criteria (or limits) for each test. The test specification section of this document is created directly from the EQP file name

listed on the cover. This document is an abstraction of the EQP file used to perform the service and is generated directly from the

electronic Agilent Equipment Qualification Plan (eEQP) Editor. The purpose of this document is to allow the user to review and record

approval of the EQP that guides the delivery of compliance services provided by the Agilent Automated Compliance Engine.

Statement of Intent

Unless otherwise requested, the qualification is delivered according to the standard test program described in the

Agilent_Recommended EQP. Agilent defines variances as changes to the default recommended values (as stated in the Agilent

Recommended EQP) that fall within a well-defined range. These changes are considered to be within the intended use range of the

system under test.

Customizations are values that (a) subject the system to limits that exceed the typical operational range or (b) additional tests that are

not considered part of the core program required for completion of the selected service. Because custom setpoints and limits may

exceed the operational envelope of the equipment, Agilent reserves the right to warrant conformance only to the closest variance

value. The user is notified of this stipulation at EQP setup time and the qualification report (EQR) will reflect this situation.

A set of ink signature fields, as determined by the creator of this document, can be included at the end of this document. All fields

should be completed or a single set of fields, initialed by an appropriate approver, run through any signature fields that are not to be

used. This is an optional process that allows a paper record of signoff by the appropriate reviewers where a hybrid (electronic/ink)

signature SOP is followed. If this document will be saved electronically and digitally signed in a document management system, it

should be generated without ink signature fields. Signing this document is for the customer's internal documentation purposes, to

assist with the applicable regulatory requirements. It is available for customer review, but it is not a pre-requisite for the delivery. The

delivery of the services is done according to the terms and conditions stated in the corresponding service exhibit. It is recommended

that after approval, this EQP be archived with the electronic EQP file.

Understanding the Test Specification Section in Tabular Review Documents

(Applies to hardware qualifications only)

For Agilent-recommended setpoints and limits, the range of allowable values (L for low, H for high) is included. As applicable,

variances, customizations, and additional setpoints are listed beneath the Agilent recommended values and marked W (within range)

or O (outside of range) in the left margin; values for added setpoints are also marked W or O and displayed after all configurations

values. Dual limits are marked DW or DO. Agilent is NOT responsible for test failures for out of range setpoints and limits. Optional

tests that are enabled are included and marked as such; required tests that are disabled by the customer are included and marked as

such.

NOTE: Limit ranges must be more tightly managed than setpoint ranges because they often reflect physical measurement limits and

are directly linked to the testing method. Therefore *within range* user limits are subject to best effort repairs if they cannot be met. In

particular, Agilent will not be responsible for test failures for limits tighter (more demanding or challenging) than the recommended

values.

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Customer Responsibilities

o Safely store and archive this EQP

o Maintain change control and revision history

o Review and optionally sign the EQP, making sure the service delivery is what was approved

o Review and approve any of the following variances from the Agilent recommended:

-Within Variance Range: changes to the Agilent recommended that are identified by Agilent as within the operation ranges

determined in our test development

-Outside of Variance Range: changes to the Agilent recommended that Agilent identifies as outside of the operational ranges

determined in our test development. Agilent is not under any obligation to make the instrument pass the more stringent limits that fall

in this range and this detail is called out in the EQP Test Specification

-Optional Tests: additional tests that are available but not part of the core testing suite and cost extra

-Disabled Tests: test for which all possible configurations have been disabled (tests are flagged in the test specification)

Agilent Responsibilities

o Deliver the services following the test programs described in the customer EQP

o Provide a locked and e-signed Qualification Report (EQR) upon completion of the service

o If requested, provide an optional ink-signed EQR CD to the customer

General Statements on the Testing Program

The recommended set of hardware OQ tests described in this EQP derives from Agilent's interpretation of authoritative expert

literature issued by the FDA, USP, GAMP, ASTM 2500, and others. The OQ test design incorporates both modular and holistic testing,

which is a proven approach, acceptable to regulators. As prescribed by the 4Q qualification methodology for Analytical Instrumentation

Qualification (AIQ), the OQ step is separated from the PQ as recommended by the regulatory guidelines.

Agilent CrossLab Compliance uses a balanced selection of metrology and chemical tests to directly determine the performance of the

systems without unnecessary reliance on inferred or derived results. For example, direct metrology is used to test pump flow rates and

thermal-controlled column compartment and autosampler modules. Holistic chemical testing is used for the evaluation of the following

critical instrument characteristics: linearity, precision, signal to noise, and carry over.

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Agilent CrossLab Compliance Services Agilent CrossLab is designed to fit traditional quality systems used by firms and recognized by regulatory agencies worldwide. Note: Enterprise Edition has been renamed Agilent CrossLab Compliance; all functionality remains the same.

How Agilent CrossLab aligns with a traditional, paper-based methodology: • Policy documents dictate the need for validation and qualification of GMP/GLP systems and usually mention the

DQ/IQ/OQ/PQ model. The precise procedures for IQ and OQ for each type of equipment are prescribed in an approved SOP, perhaps called SOP #123: Qualification of HPLC Systems. In Agilent CrossLab, the equipment qualification plan (EQP) has the same role as the traditional qualification SOP.

• The traditional SOP provides lists of tests and limits for the range of system configurations found in the laboratory. The EQP follows this concept. The inventory of systems covered by an SOP or EQP changes over time, so this is kept as a separate record.

• The traditional qualification SOP typically has blank results forms as attachments to be photocopied for each IQ or OQ event–the results recorded in ink with manual calculations. In Agilent CrossLab, this execution process is streamlined and automated by use of Adobe forms and the Agilent Compliance Engine (ACE) delivery tool. It provides reports with no hand-writing errors; validated calculations; automated pass/fail report; traceability to raw data and the number of times a test was run. This automation provides efficiency and enforces compliance to procedure.

• The traditional qualification SOP is approved and released only once–replacing the need to author individual protocols for each chromatography system. This is the same concept for the EQP. The appropriate tests for each individual configuration are automatically selected by ACE from the list in the approved EQP–at time of delivery. The final reports are unique for each system and each qualification event–but the single approved EQP can cover a lab, department, or as wide a scope as desired.

• In the traditional qualification methodology, there is no convenient provision to record the actual workflow of the tests execution and results. In the event that a test is repeated during the Agilent CrossLab delivery, ACE maintains a counter per test which is automatically incremented for GxP compliant work, and the engineer generates a deviation note within the ACE report.

HOW AGILENT CROSSLAB COMPLIANCE SERVICES WORK

Agilent CrossLab Compliance Services

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Design Qualification (DQ) DQ for commercial lab instruments is recommended by some, but not all, guidances and procedures. Definitions of DQ found in guidances and firm-specific validation procedures vary widely around the world. Some firms require nothing more than a record (such as certificate) from the instrument manufacturer demonstrating that the lab system has been designed for purpose and manufactured to a quality standard. Others treat DQ as the development of a user requirement specification document (URS) which can be matched to the IQ and OQ specifications for a manufacturer. Other firms consider DQ as including the vendor selection activities. USP Chapters literature definition of DQ: Design qualification (DQ) is the documented collection of activities that define the functional and operational specifications of the instrument and criteria for selection of the vendor, based on the intended purpose of the instrument. Design qualification (DQ) may be performed not only by the instrument developer or manufacturer but also may be performed by the user. The manufacturer is generally responsible for robust design and maintaining information describing how the analytical instrument is manufactured (design specifications, functional requirements, etc.) and tested before shipment to users. Nonetheless, the user should ensure that commercial off-the-shelf (COTS) instruments are suitable for their intended application and that the manufacturer has adopted a quality system that provides for reliable equipment. Users should also determine capability of the manufacturer for support installation, services, and training. For your reference, Agilent provides the following statements for DQ purposes: 1. All Agilent hardware and software laboratory products including the ACE software used to deliver qualification services,

are designed, manufactured, and tested according to Agilent internal Quality Life-Cycle Development Procedures. 2. Certificates of Agilent testing, validation, and conformance to standards are provided with new Agilent instruments and

similar certification is provided for ACE software. These documents are checked and recorded in Agilent CrossLab Compliance Services IQ.

3. Agilent maintains information describing how products are manufactured and maintains a problem and bug reporting program as required by international software quality guidelines.

4. The OQ specifications in this EQP can be used, as appropriate, by the user to prepare URS. The OQ specifications in this EQP represent the levels of performance acceptable to regulatory agencies for the technique; conform to typical specifications found in validation literature; are equally suitable for OQ at installation and on-going OQ throughout operational lifetime; are equivalent to the OQ specifications published in the legacy Agilent Classic OQPV protocols; and are suitable for most user requirements.

5. Agilent Technologies is capable of installation, support, preventive maintenance, on-going qualification, and re-qualification after repair and user training worldwide.

Installation Qualification (IQ) IQ checks and tests for Agilent hardware and software products include the following: 1. Purchase Order Details: Allows the customer to verify that the instrument being qualified matches their design

requirements (if available) and purchase order. 2. Preparation and Installation Details: Gathers and records information about preparation and installation documents. 3. Documentation: Gathers and records information about reference and user manuals for initial installations. 4. Product Quality Assurance Details: Collects and records certificates and other forms that verify that the vendor has

developed and built the product according to internal standards. 5. Startup: Verifies that all modules start up properly. 6. Instrument Check (hardware only): Demonstrates that all modules of the instrument are correctly installed and connected.

It does not test instrument performance as fully as OQ. This test is not necessary and therefore skipped if an OQ is to be performed by Agilent operator at installation after IQ.

7. Installation Verification (software only): Verifies the correctness of all installation-related files.

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Operational Qualification (OQ) Refer to the appropriate Test Definitions document for a detailed description of the testing program, setpoints, and acceptance limits for each system technique, category, and instrument configuration.

Dual-Acceptance Limits (Applies to hardware qualifications only) Within the EQP of Agilent CrossLab, each of the tests final result can be compared against two different limits if required. This allows customer-configured OQ to report against a User Limit (Limit 1) and the Agilent Recommended Limit (Limit 2) simultaneously. In the standard EQP documents, Limit 1 and 2 values are the same – effectively de-activating this feature. Custom EQPs can also be prepared on request, making effective use of the two-limit feature of the Agilent Compliance Engine (ACE). In those cases, Limit 2 will always be the Agilent Recommended limit, and Limit 1 will be the limit requested by the user. Agilent will not be under any obligation regarding the OQ testing results against user-requested limits that are more stringent than the Agilent Recommended ones.

Re-Qualification after Repair (RQ) Hardware (Applies to hardware qualifications only) In the event of a hardware breakdown followed by an engineering repair of a qualified instrument, it is necessary to re-qualify the system to an appropriate level before release back into operational use. For some of the instrument techniques, Agilent offers a service contract to repair and re-qualify an instrument during the period between scheduled annual OQs. The level of re-testing is prescribed in the RQ section of ACE: a form is displayed for the operator showing all types of repair possible and the re-testing required. Part of an example form is shown below.

Re-Qualification After Repair Pump Strategies

Repair/Replace Strategy Modules OQ/PV Testing Internal pump head parts, active inlet valve (or AIV cartridge), (parts of) check valves, reference valves, inlet manifold or pump drive, or taking pump head apart to clean (versus repair)

Any pump Flow Accuracy & Precision

Pulse damper, pressure transducer Any pump Flow Accuracy & Precision Multi-channel gradient valve Quaternary Flow Accuracy & Precision

Gradient Composition The full list of repair and re-test guidance is available for review by customers of the RQ service. The RQ form in ACE prescribes which tests the operator must perform for each repair circumstance. The test procedure, setpoints, and limits will be an exact repeat of the previous OQ test (a regression-testing strategy).

Updated: June 2015 www.agilent.com/crosslab/compliance-steps Information, descriptions and specifications in this

publication are subject to change without notice.

© Agilent Technologies, Inc. 2017 Published in USA

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Overview Agilent CrossLab qualification services offer flexible choices for the delivery method as descried below. The desired service delivery method is chosen according to the laboratory data integrity and general procedural requirements. To ensure complete data traceability, Agilent has devised two delivery methods that access data directly (default methods). An alternative method is also available that accesses data indirectly through a transfer location. If neither of the default methods is chosen, this document captures customer approval of the alternative delivery method.

Available Methods Method Definition

Preferred 1 Network-distributed ACE (NDA), where the ACE software is installed on a network node within the laboratory LAN infrastructure. Requires collaboration with the customer to load ACE behind the customer firewall. Raw data locations are always captured in the equipment qualification report (EQR), which provides end to end traceability and a fully characterized data workflow in the delivery.

Preferred 2 Dedicated spinning USB drive, where the ACE software resides on an independent drive that can be driven from the system controller, where the CDS resides. Because the USB spinning drive is connected to the CDS, the validity of this method is equivalent to the preferred 1 method. Raw data is imported directly into ACE by the Data Manager tool, with the data paths always captured in the report, which provides data traceability assurance. This is the most commonly used method.

Alternative The ACE software is installed on and run from a PC not directly connected to the customer data system (CDS), such as the FSE’s laptop. System data files are transferred indirectly from the CDS to the laptop instead of directly like preferred 1 and 2 methods. Requires customer pre-approval to remove later questions on data integrity.

Customer Approval of Alternative Method Approved by/title:

Comments:

Updated: May 2017 www.agilent.com/crosslab/compliance-steps Information, descriptions and specifications in this

publication are subject to change without notice.

© Agilent Technologies, Inc. 2017 Published in USA

SERVICE DELIVERY METHODS CUSTOMER APPROVAL OF ALTERNATIVE METHOD

Agilent CrossLab Compliance Services

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Standard OQ Test Suite This document describes the test program for qualifying SFC Agilent systems; the following table lists all OQ tests.

Key: Fixed setpoints/limits Variance allowed Test Setpoints and Parameters Limits C02 Flow Accuracy and Precision

Flow rate 1: 5.000 ml/minute (1.000 – 5.000) Flow rate 2: 1.000 ml/minute (1.000 – 5.000) Each flow rate tested at 150 and 200 bar back pressure

Accuracy ≤ 10.00% (5.00 – 15.00) Precision ≤ 5.00% (5.00 – 10.00)

Gradient Composition 80, 60, 40, and 20% steps Accuracy ≤ 4.00% (4.00 – 8.00) Gradient Linearity Slope and Step

Coeff. of det. ≥ 0.990% (0.985 – 0.999, slope) Coeff. of det. ≥ 0.9990% (0.9900 – 0.9999, step)

Gradient Mixing Efficiency 20% step Efficiency ≥ 99.0% (95.0 – 99.0) Modifier Flow Accuracy and Precision

Flow rate 1: 5.000 ml/minute (1.000 – 5.000) Flow rate 2: 0.500 ml/minute (0.200 – 0.999)

Accuracy ≤ 5.00% (5.00 – 10.00, flows ≥1.000 ml/minute) Accuracy ≤ 10.00% (10.00 – 20.00, flows 0.2 – 0.999 ml/minute) Precision ≤ 1.00% (1.00 – 5.00, flows ≥1.000 ml/minute) Precision ≤ 5.00% (5.00 – 10.00, flows 0.2 – 0.999 ml/minute)

Column Compartment Temperature Accuracy and Stability

Temperature 1: 60.0°C (10.0 – 80.0) Temperature 2: 40.0°C (10.0 – 80.0) Stability measured at temperature 2

Accuracy ≤ 2.0°C (1.0 – 5.0) Stability ≤ 1.0°C (0.5 – 3.0)

Noise and Drift (DAD, MWD)

ASTM baseline noise Slope of regression fit for drift Wavelength: 254 nm

Noise: ≤ 0.150 mAU (0.10 – 5.000) Drift ≤ 5.000 mAU/hour (4.000 – 50.000)

Back Pressure Noise Back pressure: 200 bar Noise ≤ 1.0 bar (0.5 – 2.0) Scouting Run Injection volume on column: 5 µl (1 – 20) N/A Injection Precision (DAD, MWD)

Height RSD ≤ 2.00% (1.00 – 5.00) Area RSD ≤ 2.00% (1.00 – 5.00) Retention time RSD ≤ 2.00% (1.00 – 5.00)

Injection Carry Over (DAD, MWD)

Height carry over ≤ 0.10% (0.10 – 2.00) Area carry over ≤ 0.10% (0.10 – 2.00)

Wavelength Accuracy (DAD, MWD)

DAD Injection volume: 5 µl (1 – 20) MWD flow cell is filled manually Wavelength 1: 203 Wavelength 2: 273

Accuracy Wavelength 1: ≤ 3 nm (3 – 4) Accuracy Wavelength 2: ≤ 2 nm (1 – 4)

Response Linearity (DAD, MWD)

Injection volume on column: 5 µl (1 – 20) Coeff. of det. (r2) ≥ 0.99900 (0.99000 – 0.99990)

Sample Temperature Accuracy

Temperature: 4.0°C (4.0 – 40.0) Samples four vials of methanol in different tray positions

Diff. from setpoint ≥ -2.0°C (-5.0 – -1.0) and ≤ 5.0°C (4.0 – 6.0)

SUPERCRITICAL FLUIDS CHROMATOGRAPHY (SFC) AGILENT SYSTEMS OPERATIONAL QUALIFICATION

Agilent CrossLab Compliance Services

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Test Design and Rationale Overview Many GMP/GLP enforcement agency inspectors now ask firms to provide a risk assessment of their equipment and computer systems plus a science-based rationale for subsequent validation and qualification testing. GENERAL RISK STATEMENT: Any laboratory chemical system used for raw material testing or final drug product / medical device testing in GMP or used in formal GLP studies will likely fall into a HIGH RISK category. This risk assessment will imply the need for IQ & OQ & on-going qualification. ANY USER SPECIFIC RISK ANALYSIS SUPERCEDES THIS GENERAL RISK STATEMENT. The rest of this section outlines the science-based rationale for each test in the Agilent hardware OQ plus a brief test design and procedure description. The recommended set of hardware OQ tests described in this EQP derives from Agilent’s interpretation of FDA, USP, and GAMP guidelines and other authoritative expert literature. OQ test design incorporates both modular and holistic testing, which is a proven and regulatory acceptable approach. When applicable, direct metrology is used to test pump flow rates and thermal-controlled column compartments, for example. Holistic chemical testing is used to evaluate critical instrument characteristics When applicable, certified reference standards and calibrated equipment are used. Considering the number of setpoints, parameters, and conditions of each recommended OQ test, the proven concepts of worst case, range, and representative have been applied. If a property or characteristic is known to have its worst performance at one end of a range of use, this is the setpoint that should be tested and other setpoints are not required. If a property or characteristic has no known worst case, testing at the high and low points of the range of use is required. If there are too many possible use cases and conditions to realistically test (and none is a worst case), a representative sample for test is the best approach.

CO2 Flow Accuracy and Precision Description: This test measures CO2 flow at a high pressure to test actual pumping conditions. Any large pressure drop within the system causes a change in fluid density and a resulting change of volumetric flow rate, so measurements must be taken as close to the pump outlet pressure as possible. Procedure: A CO2 flowmeter is installed directly after the pump and six consecutive reading are collected at different flows and different backpressures. Accuracy is calculated as the absolute % difference of the mean of the six flow readings against the setpoint; precision is calculated as the %RSD of the six flow readings.

Gradient Composition Description: Accuracy and stability of solvent mixing online is critical for consistent and accurate quantitative analysis. Gradient composition is also important for comparing systems and transferring methods. Procedure: An acetone tracer is used to determine the solvent gradient composition accuracy, stability, and linearity. The system is challenged with a linear ramp-up from 0 to 100% where the composition linearity is determined using the ramp data between 5 and 95% of the ramp. The ramp-up is followed by a step-down gradient with steps at 80, 60, 40, and 20%. All composition accuracies are calculated as the absolute difference between the mean composition at each setpoint and the theoretical composition. For the 20% step, a mixing efficiency is calculated as a ratio between the noise level and height at that step.

Modifier Flow Accuracy and Precision Description: Flow accuracy and precision is important for comparing systems and transferring methods. Procedure: A calibrated digital flowmeter is attached to the waste line of the system with 100% methanol flow at representative back pressure provided by the installed column. Six readings are taken at each setpoint to determine the flow accuracy and precision. Accuracy is calculated as the absolute % difference of the mean of the six flow readings against the setpoint; precision is calculated as the %RSD of the six flow readings.

Column Compartment Temperature Accuracy and Stability Description: Temperature accuracy is important for comparing systems and transferring method, and temperature stability is critical for repeatability of peak height, area, and retention time. Procedure: A calibrated digital temperature meter and a proprietary probe are used to measure the temperature of the column compartment heat exchanger. A typical column compartment temperature range of use is tested. After stabilization, the temperature accuracy is calculated as the absolute difference between what was measured and the setpoint. After accuracy readings are completed at the low end of the range, six readings are taken every four minutes and temperature stability is expressed as the delta between the highest and lowest measured temperatures (all in Celsius).

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Noise and Drift Description: This test indicates detector sensitivity and stability. Procedure: The signal is monitored at a specific wavelength within a 20-minute interval over a 24-minute period. Noise is calculated as the average peak-to-peak noise in a number of signal segments (ASTM noise), and drift is calculated as the slope of the linear regression of the signal.

Back Pressure Noise Description: This test expresses stability as the delta between the highest and lowest pressures. Procedure: Noise is determined by peak to peak variations in the BPR pressure trace collected during the noise and drift test.

Scouting Run Description: This test is used to determine the chromatogram for presence of expected peaks, sufficient run time, and proper integration events prior to the start of the actual qualification runs.

Injection Precision Description: The test evaluates area, height, and retention time of a traceable caffeine standard. Retention time stability is an indirect control of proper function of the temperature and flow. Area and height stability are measured for a stable injection. Procedure: Using a traceable standard, six injections from the same standard are made; area, height, and retention time are determined and their averages and RSDs calculated.

Injection Carry Over Description: Low carry over from a previous injection is critical for accuracy of quantitative and reliability of qualitative analysis. This test challenges the injector system in the SFC system. Procedure: Following the six-injection precision test, a blank injection is made. The carry over result is calculated as a ratio of the area of any residual peak found in the blank injection to the area of the previous injection (expressed as a percentage).

Wavelength Accuracy Description: Wavelength accuracy is critical for accuracy of quantitative and qualitative analysis. Wavelength accuracy is also important when comparing systems and transferring methods. Procedure: During the Injection Precision test, spectral data is collected (DAD), or the flowcell is filled with caffeine standard manually (MWD). Maximum wavelengths are compared against an expected result. Accuracy is expressed as the absolute difference between the measured and defined wavelength.

Response Linearity Description: The linearity of a detector is critical for establishing reliable and accurate quantitative results. It is also important when comparing systems and transferring methods. Procedure: A series of five traceable standards that represent a typical concentration range are injected and evaluated. The response linearity is calculated by determining the coefficient of determination (r2) of the peak areas versus concentration.

Sample Temperature Accuracy Description: Thermostat accuracy is important when comparing systems and transferring methods. Procedure: Four vials are filled with methanol and allowed to equilibrate to the temperature setpoint. Similar to the column compartment, the temperature of the methanol is measured using a traceable digital temperature meter and proprietary probe.

Updated: November 2017 www.agilent.com/crosslab/compliance-steps Information, descriptions and specifications in this

publication are subject to change without notice.

© Agilent Technologies, Inc. 2017 Published in USA

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Report and Delivery Options- Show chromatograms

- Show header and footer on cover

Selected Signature OptionsStatus: EQP is not signed

- Setpoint/Limit variance is allowed in this EQP

- Reporting variance is allowed in this EQP

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Customer Approval

Name:

Title:

Date:

Signature:

Name:

Title:

Date:

Signature:

Name:

Title:

Date:

Signature:

Name:

Title:

Date:

Signature:

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

Legal NoticeAgilent CrossLab Compliance and its primary components (ACE software tool, procedures, test design, metrology tools, chemical

reference standards, and operator training materials) have been designed, tested, validated, and released for commercial use

following Agilent's Life-Cycle Development Quality Assurance methodology.

Date: November 2017

Agilent CrossLabs Group R&D VP and Dir. of Technology: Neil Cook. Santa Clara, California USA.

Agilent CrossLabs Group Quality Manager: Julio Hector. Santa Clara, California USA.

Agilent CrossLab Compliance is endorsed by Dr. Ludwig Huber on behalf of labcompliance.com.

ACE software is patented. Copyright is claimed by this statement for all original work comprising Agilent CrossLab Compliance. Any

unauthorized use, reproduction, or translation will be prosecuted to the maximum extent possible by law. All customer copies of EQP

approval, final qualification reports, and raw data provided to customer at delivery of the service become the property of the customer.

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© 2017 by Agilent Technologies Agilent CrossLab Compliance Services

NOTE: The Revision History - EQP Editor document includes details for above and other available revisions.

SFC.01.08 July 2017

Protocol Revision Used for this Document Protocol Revision Release Date

Protocol Details

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